REVIEW OF CLINICAL STUDIES

Clinical Study Outline for Chinese NDA

Site: The Clinical Study was performed at Xiyuan Hospital of China: Academy of Traditional Chinese Medicine, Beijing PRC in 1999.

Patients: 30 individuals ages (11 male 19 female) age 18-37, average course of disease 3-5 years

Treatment: AcnEase^® 8 tablets/day for 30 days

Efficacy: Decrease in the number and severity of skin lesions, white heads and black heads. Serum testosterone and facial corynebacteria determinations were performed.

Safety: Clinical Chemistry, Hematology, Urine Analysis and Adverse Events

Results: Over 80 % Response Rate Following 1 month of Treatment

Methods: Acne was measured before and after treatment. Severe acne was rated a score of 3, medium acne a score of 2 and light acne assigned a score of 1. One measure of efficacy was measured as follows: for every improvement in the grade of severity of 2 units, a remarkably effective rating was assigned, an improvement in score of 1 unit was classified as effective. For example if an individual was rated a score of 3 and after therapy was reduced to a score of 1 this was considered remarkably effective.

For quantitative measurements each acne lesion was assigned a score (1-3) and the total score for each participant recorded before and after treatment. For this case if the total score decreased by >70% the response was rated remarkably effective, if the accumulated score decreased by >30% the response was ranked effective and less then 30% decrease in score was rated ineffective.

Results:

Table 1

Change in the Mean Number of Acne Lesions

In this assessment of efficacy AcnEase^® caused a greater then 50% reduction in the number of each type of acne lesion.

Table 2

Change in Accumulated Acne Scores

The decrease in the accumulated score, which takes into account the severity, and extent of acne was dramatic. Within 1 month the accumulated scores for white heads and black heads decreased by approximately 75% and 65% respectively. The number and severity of inflammatory papules also decreased by over 65%.

Evaluation of the level of effectiveness as judged by the extent of decrease observed for each patient revealed that 7/30 patients were scored as remarkably effective, 17/30 were judged to be effective with the remaining 6/30 judged not effective, yielding an overall effectiveness rating of 80%.

Analysis of the level of corynebacteria associated with the acne lesions was reduced nearly 50% but the small sample size did not yield statistical significance. The levels of serum testosterone did not change following treatment.